Market Newsdesk

SAN DIEGO, June 15, 2021 (GLOBE NEWSWIRE) — Progenity, Inc. (Nasdaq: PROG), an innovative biotechnology company, today announced that Harry Stylli, PhD, CEO, chairman of the board, and co-founder of Progenity, will participate in a fireside chat at the virtual Raymond James 2021 Human Health Innovation Conference at 10:40 a.m. ET / 7:40 a.m. PT on Tuesday, June 22, 2021.

A live webcast and archive of the fireside chat will be available online from the investor relations section of the company website at www.progenity.com.

About Progenity

Progenity, Inc. is a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity’s vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

For more information about Progenity’s products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

Investor Contact:

Robert Uhl
Managing Director, Westwicke ICR
[email protected]
(619) 228-5886

Media Contact:

Kate Blom-Lowery
CG Life
[email protected]
(858) 457-2436

HARRISBURG, Pa., June 15, 2021 (GLOBE NEWSWIRE) — Ollie’s Bargain Outlet Holdings, Inc. (Nasdaq: OLLI) announced today that the Company will be participating in a fireside chat at the 2021 Jefferies Virtual Consumer Conference on Tuesday, June 22, 2021, at 2:05 PM ET. Attending for Ollie’s will be John Swygert, President and Chief Executive Officer, and Jay Stasz, Senior Vice President and Chief Financial Officer.

The audio portion of the fireside chat will be webcast live over the internet and can be accessed by logging on to the Investor Relations section on the Company’s website at http://investors.ollies.us/. An online archive will be available for a period of 90 days following the presentation.

About Ollie’s

We are a highly differentiated and fast growing, extreme value retailer of brand name merchandise at drastically reduced prices. We are known for our assortment of merchandise offered as Good Stuff Cheap®. We offer name brand products, Real Brands! Real Bargains!®, in every department, including housewares, food, books and stationery, bed and bath, floor coverings, toys, health and beauty aids and other categories. We currently operate 407 stores in 28 states throughout half of the United States. For more information, visit www.ollies.us.

Investor Contact:

Jean Fontana
ICR
646-277-1214
[email protected]

Media Contact:

Tom Kuypers
Senior Vice President – Marketing & Advertising
717-657-2300
[email protected]

MONTREAL, June 15, 2021 (GLOBE NEWSWIRE) — Vision Marine Technologies, Inc.(Nasdaq: VMAR) (“Vision Marine” or the “Company”) a leading manufacturer in the electric recreational boating industry serving both OEMs and consumers, is pleased to announce today that the Company will partner with Hellkats Powerboats to showcase the capabilities of its proprietary technology by rigging a Hellkats 32’ Super-Sport Widebody Catamaran with a twin application of its groundbreaking E-Motion™ powertrain system. This limited edition “Fulgura I” is scheduled to be on the water in November 2021. Center Console Only (“CCO”), a well-known voice in the boating industry, intends to document the process, ranging from manufacturing the boat, installing the technology, and filming the event.

“We thoroughly appreciate and respect innovators working to push the boating industry forward.  Vision Marine has truly created something special, and we are honored to have the opportunity to showcase its revolutionary E-Motion™ powertrain system. The combination of Vision Marine and Hellkats Powerboats is guaranteed to turn heads,” said Alan Blanco, CEO of CCO.

“My team and I are extremely excited to partner with Hellkats. This is the perfect opportunity to showcase the capability, reliability and power of our E-Motion powertrain”, stated Alexandre Mongeon, co-founder and CEO of Vision Marine. With top speed expected to surpass 100 mph (160 km/h), Vision Marine intends to position itself as the uncontested leader in the electric boating industry, and moreover, a truly disruptive force to penetrate the traditional ICE boating industry.

After the event, where the “Fulgura I” is expected to shatter the world record for its category, the boat will be auctioned off, with all proceeds going to select charities tied to furthering the awareness and cleanup of waterways globally. Mr. Mongeon expressed his strong commitment and continuing mandate to keep waterways clean and safe from pollutants “Vision Marine has always been dedicated to lessening reliance on fossil fuels. This is yet another way for us to help keep our waterways pollution free for future generations”, states Mr. Mongeon.

About Vision Marine Technologies, Inc.


Vision Marine Technologies, Inc., strives to be a guiding force for change and an ongoing driving factor in fighting the problems associated with waterway pollution by disrupting the traditional boating industry with electric power, in turn directly contributing to zero pollution, zero emission and a noiseless environment. Our flagship outboard powertrain (“E-Motion™”) is the first fully electric purpose-built outboard powertrain system that combines an advanced battery pack, inverter, and high efficiency motor with proprietary union assembly between the transmission and the electric motor design utilizing extensive control software. Our E-Motion™ and related technologies used in this powertrain system are uniquely designed to improve the efficiency of the outboard powertrain and, as a result, enhance both range and performance. Vision continues to design, innovate, manufacture, and sell our handcrafted, high performance, environmentally friendly, electric recreational power boats to customers. The design and technology applied to our boats results in far greater enhanced performance in general, higher speeds, and longer range. Simply stated, a smoother ride than a traditional ICE motorboat.

About Hellkats Powerboats


We are a leading boat manufacturer, specializing in powerboats and using the latest advancements with the infusion of fiberglass and core construction in our hulls and decks. We use state-of-the-art materials in all our powerboats. Our company motto is not only to have a good looking and fast catamaran, but one that is safe and is built with the best labor and material in the market.

We are a leading performance catamaran boat builder in south Florida.  Our most popular performance is a 30’ Sport Catamaran that as of January 2020, holds the unofficial record for being the fastest 30;/44’ small tunnel catamaran that has run up to speeds of 124 mph.

About CCO


At Center Consoles Only, we work relentlessly to create unique content while telling a story that consistently prompts high-quality engagement from our growing community of boating enthusiasts. We offer marine manufacturers highly customizable solutions ranging from production shoots, reviews to live-streams. Our mission is to inform, educate and entertain those in the boating community, one experience, one sea trial and one conversation at a time.

Forward-Looking Statements


Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, actual results may differ materially from these expectations due to changes in global, regional, or local economic, business, competitive, market, regulatory and other factors, many of which are Vision’s control. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Vision’s Annual Report on Form 20-F, filed with the SEC for the year ended December 31, 2020, as such factors may be updated from time to time in Vision’s periodic filings with the SEC. Any forward-looking statement in this press release speaks only as of the date of this release. Vision undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

https://visionmarinetechnologies.com

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Investor and Company Contact:

Bruce Nurse
Vision Marine Technologies, Inc.
(800) 871-4274
[email protected]

Dave Gentry
RedChip Companies Inc.
800-RED-CHIP (733-2447) or 407-491-4498
[email protected] 

MALVERN, Pa., June 15, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that it has selected Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for COVAXIN™ to prepare for potential commercial manufacturing of COVAXIN™ for the US and Canadian markets.

“We are fully committed to bringing COVAXIN to the US and Canadian markets because we believe it has the potential to save lives by adding a weapon to the arsenal in the fight against emerging variants,” said J.P. Gabriel, Ocugen’s Senior Vice President, Manufacturing and Supply Chain. “Securing US-based manufacturing capability is a critical step as we prepare to submit our regulatory submissions to the FDA and Health Canada. Based on Bharat Biotech’s strong track record of developing and commercializing vaccines globally and Jubilant’s proven track record in manufacturing, we are well-prepared to transition US manufacturing of COVAXIN to our new partner.”

“We are excited to expand our basket of vaccine products and meet the increasing demand from our customers for COVID-19 vaccines in the US,” said Amit Arora, President Jubilant HollisterStier.

“We are pleased to partner with Ocugen and support the ongoing fight against COVID-19. With two facilities in North America working to manufacture multiple COVID-19 vaccines and therapies, we remain committed to supporting efforts to eradicate this global pandemic,” stated Pramod Yadav, CEO Jubilant Pharma Limited.

About COVAXIN™

COVAXIN™, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform. This platform has an excellent safety track record of more than 300 million doses of various vaccines supplied. Based on a traditional vaccine platform that has a long-established safety profile, COVAXIN™ continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of Bharat Biotech’s Phase 3 clinical trial.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to published safety data from separate studies for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8⁰C.

COVAXIN studies show potential effectiveness against three key variants of SARS-CoV-2. Scientists at the Indian Council of Medical Research (ICMR)-National Institute of Virology, using an in-vitro plaque reduction neutralization assay, have found that COVAXIN-vaccinated sera effectively neutralized the Brazil variant of SARS-CoV-2, B.1.128.2, the alpha variant, B.1.1.7, which was first identified in the United Kingdom, as well as the delta variant, B.1.617, which was first identified in India. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

Based on the more than 30 million doses supplied in India and other countries, COVAXIN has an excellent safety record. COVAXIN is currently being administered under emergency use authorizations in 13 countries, and applications for emergency use authorization are pending in more than 60 additional countries.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

About Jubilant HollisterStier

Jubilant HollisterStier, a part of Jubilant Pharma Limited, is a leading integrated contract manufacturer of sterile injectables, ophthalmics, otics, sterile and non-sterile topicals and liquids. With facilities in North America, Jubilant HollisterStier provides specialized manufacturing for the pharmaceutical and biopharmaceutical industries. Services include a full-range of support to streamline the manufacturing process, from process qualifications through commercial release.

About Jubilant Pharma Limited

Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and Non Sterile products through six US FDA approved manufacturing facilities in the US, Canada and India and a network of 48 radiopharmacies in the US. The Company has a team of around 5,200 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a ‘Partner of Choice’ by leading pharmaceutical companies globally.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the interim data from Bharat Biotech’s Phase 3 trial in India), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether we will be able to provide the U.S. Food and Drug Administration (FDA) with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA), the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA; any additional chemistry, manufacturing and controls information that we may be required to submit the timing of our BLA filing; whether and when an application for authorization under interim order for emergency use will be filed in Canada; whether and when any such applications may be approved by Health Canada; whether developments with respect to COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:

Ocugen, Inc.

Sanjay Subramanian
CFO and Head of Corp. Dev.
[email protected] 

Media Contact:

LaVoieHealthScience

Lisa DeScenza
[email protected] 
+1 9783955970

Dallas, June 15, 2021 (GLOBE NEWSWIRE) — Thryv Holdings, Inc. (NASDAQ:THRY) (“Thryv”), the provider of Thryv^® software, the leading end-to-end customer experience platform built for growing small businesses, announced it will be hosting Connect: Home Services on June 23, 2021. The event is designed exclusively for the Home Services industry. Attendees can join the free virtual event to network with other business owners in the home services industry and learn actionable growth strategies from speakers who are experts in their field. 

“Home services businesses value Thryv’s SaaS platform because it helps them attract more customers and get paid faster,” said Joe Walsh, CEO and President of Thryv. “After the success of our Connect for HVAC Contractors in April, we decided to dedicate this Thryv Connect to our community of clients in the Home Services industry to discuss the latest consumer, economic, and small business trends – and share modern techniques for wowing homeowners so they become customers for life.” 

Thryv Connect: Home Services attendees will learn first-hand from experts how to get jobs and get paid by providing an experience that the modern consumer expects. Attendees will have an opportunity to learn more about business software whether they consider themselves a technology beginner or a pro.  The event will close with interactive roundtable discussions with the featured speakers.   

“Home service businesses are expected to still boom after the pandemic, but they need to offer more than an excellent product,” said small business expert Barry Moltz, a featured speaker at the event. “These companies must provide an outstanding experience that customers now require. We will show them how to use technology to make that easy.”

Save your seat now for Connect: Home Services at connecthomeservices.thryv.com. 

About Thryv Holdings, Inc.

Thryv Holdings, Inc. owns the easy-to-use Thryv® end-to-end customer experience software built for growing small to medium sized businesses (SMBs) that helps over 40,000 SaaS clients with the daily demands of running a business. With Thryv®, SMBs can get the job, manage the job and get credit. Thryv’s award-winning platform provides modernized business functions, allowing SMBs to reach more customers, stay organized, get paid faster and generate reviews. These functions include building a digital customer database, automated marketing through email and text, updating business listings across the internet, scheduling online appointments, sending notifications and reminders, managing ratings and reviews, generating estimates and invoices, and processing payments.

Thryv supports franchise operators and multi-location business owners with Hub by Thryv™, a software console that enables businesses managers to oversee their operations using the Thryv® software.

Thryv also connects local businesses to consumer services through our search, display and social media management products, our print directories featuring The Real Yellow Pages® tagline, and our local search portals, which operate under the DexKnows.com®, Superpages.com® and Yellowpages.com URLs and reach some 35 million monthly visitors. For more information about the company, visit thryv.com. 

Thryv delivers business services to more than 400,000 SMBs worldwide that enable these SMBs to compete and win in today’s economy.    

On March 1, 2021, Thryv announced it closed the acquisition of Sensis, Australia’s leading digital, marketing and directory services provider, which helps Australians connect and engage through its leading platforms, digital consumer businesses (Yellow, White Pages, True Local and Whereis), search engine marketing and optimization services, website products, social, data and mapping solutions, and through its digital agency Found. Sensis is also Australia’s largest print directory publisher including the Yellow and White Pages.

Headquartered in Melbourne, Sensis has a sales presence in all states and territories across Australia. 

Media Contact:  

Paige Blankenship

Thryv, Inc.

972.453.3012                                                                         

[email protected] 

Investor Contacts:  

Cameron Lessard 

Thryv, Inc.    

214.773.7022 

[email protected]   

KJ Christopher  

Thryv, Inc.    

972.453.7068  

[email protected]  

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AUBURN HILLS, Mich., June 15, 2021 (GLOBE NEWSWIRE) — SPAR Group, Inc. (NASDAQ: SGRP), a leading global provider of merchandising and marketing services, announced today that Mr. Arthur H. Baer, Mr. Igor Novgorodtsev, and Mr. Jeffrey A. Mayer, have resigned from the Corporation’s Board of Directors, effective June 9, 2021.

The management of the Corporation would like to thank Mr. Baer, Mr. Novgorodtsev, and Mr. Mayer for their service on the Board and their professional contributions. They provided experience and counsel that helped shape the Company for the future and rebuilt the Company’s leadership team. Their commitment to governance and board independence was highly valued.

Although the resigning Independent Directors expressed confidence in the CEO and the management team, as well as their respect and admiration for the fine leadership of the Company’s international and domestic joint venture partners, in their resignation letter to the Corporation, the resigning Independent Directors said they were concerned over efforts by the Company’s two major shareholders that they believe could weaken Board independence, interfere with the operations of the Company’s business, and adversely affect the Company’s liquidity and minority shareholders.

The Company has provided Nasdaq with a notice that it would be temporarily out of compliance with Nasdaq Listing Rule 5605(b)(1) requiring that Independent Directors constitute a majority of the Company’s Board, and temporarily out of compliance with Nasdaq Listing Rule 5605(c) requiring that an audit committee have at least three members and the members each be independent directors. The Corporation has begun a search for three new directors to fill vacancies on the Board and regain compliance with Nasdaq listing rules.

Additional details are available on a form 8k filed with the Securities and Exchange Commission.

About SPAR Group

SPAR Group is a leading global merchandising and marketing services company, providing a broad range of services to retailers, manufacturers and distributors around the world. With more than 40 years of experience, 25,000+ merchandising specialists around the world, an average of 200,000+ store visits a week and long-term relationships with some of the world’s leading manufacturers and retail businesses. SPAR Group provides specialized capabilities across 9 countries and 4 continents.

For more information, please visit the SPAR Group’s website at http://www.sparinc.com.

Contact:
Dave Mossberg
(817) 310-0051

Forward-Looking Statements

This Press Release contains, and the above referenced recorded comments, will contain “forward-looking statements” within the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, made by, or respecting, SPAR Group, Inc. (“SGRP“) and its subsidiaries (together with SGRP, “SPAR”, “SPAR Group” or the “Company“), to be filed shortly in a Current Report on Form 10-Q by SGRP with the Securities and Exchange Commission (the “SEC“). There also are forward-looking statements contained in SGRP’s Annual Report on Form 10-K for its fiscal year ended December 31, 2020, as filed with the SEC on March 31, 2021, and SGRP’s First Amendment to Annual Report on Form 10-K/A for the year ended December 31, 2020, as filed with the SEC on April 29, 2021 (as so amended, the “Annual Report“), in SGRP’s definitive Proxy Statement respecting its Annual Meeting of Stockholders to be held in July of 2021, which SGRP plans to file with the SEC in June of 2021 (the “Proxy Statement“), and the SGRP’s Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other reports and statements as and when filed with the SEC (including the Quarterly Report, the Annual Report and the Proxy Statement, the Information Statement, the Second Special Meeting Proxy/Information Statement, each a “SEC Report“). “Forward-looking statements” are defined in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act“), and other applicable federal and state securities laws, rules and regulations, as amended (together with the Securities Act and Exchange Act, the “Securities Laws“).

The forward-looking statements made by the Company in this Press Release may include (without limitation) any expectations, guidance or other information respecting the pursuit or achievement of the Company’s corporate strategic objectives. The Company’s forward-looking statements also include, in particular and without limitation, those made in “Business”, “Risk Factors”, “Legal Proceedings”, and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Annual Report. You can identify forward-looking statements in such information by the Company’s use of terms such as “may”, “will”, “expect”, “intend”, “believe”, “estimate”, “anticipate”, “continue”, “plan”, “project” or similar words or variations or negatives of those words.

You should carefully consider (and not place undue reliance on) the Company’s forward-looking statements, risk factors and the other risks, cautions and information made, contained or noted in or incorporated by reference into this Press Release, the Annual Report, the Proxy Statement and the other applicable SEC Reports that could cause the Company’s actual performance or condition (including its assets, business, clients, capital, cash flow, credit, expenses, financial condition, income, liabilities, liquidity, locations, marketing, operations, performance, prospects, sales, strategies, taxation or other achievement, results, risks, trends or condition) to differ materially from the performance or condition planned, intended, anticipated, estimated or otherwise expected by the Company (collectively, “expectations”) and described in the information in the Company’s forward-looking and other statements, whether express or implied. Although the Company believes them to be reasonable, those expectations involve known and unknown risks, uncertainties and other unpredictable factors (many of which are beyond the Company’s control) that could cause those expectations to fail to occur or be realized or such actual performance or condition to be materially and adversely different from the Company’s expectations. In addition, new risks and uncertainties arise from time to time, and it is impossible for the Company to predict these matters or how they may arise or affect the Company. Accordingly, the Company cannot assure you that its expectations will be achieved in whole or in part, that the Company has identified all potential risks, or that the Company can successfully avoid or mitigate such risks in whole or in part, any of which could be significant and materially adverse to the Company and the value of your investment in SGRP’s Common Stock.

You should also carefully review the risk factors described in the Annual Report (See Item 1A – Risk Factors) and any other risks, cautions or information made, contained or noted in or incorporated by reference into the Annual Report, the Proxy Statement or other applicable SEC Report. All forward-looking and other statements or information attributable to the Company or persons acting on its behalf are expressly subject to and qualified by all such risk factors and other risks, cautions and information.

The Company does not intend or promise, and the Company expressly disclaims any obligation, to publicly update or revise any forward-looking statements, risk factors or other risks, cautions or information (in whole or in part), whether as a result of new information, risks or uncertainties, future events or recognition or otherwise, except as and to the extent required by applicable law.

HOUSTON, June 15, 2021 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, today announced the initiation of a clinical trial to investigate seclidemstat, a novel lysine specific demethylase 1 (LSD1) inhibitor, as a potential treatment for hematologic cancers. This investigator-initiated Phase 1/2 trial will be led by Dr. Guillermo Montalban-Bravo from the Department of Leukemia at The University of Texas MD Anderson Cancer Center.

The trial will be an open label, dose-finding, dose-expansion study to determine the maximum tolerated dose (MTD) and the safety and tolerability of seclidemstat when used in combination with azacytidine as a treatment for Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML). MDS and CMML are blood cancers that can progress into a deadly form of leukemia, Acute Myeloid Leukemia (AML). The trial was initiated because of compelling preclinical data in which seclidemstat demonstrated anti-proliferative activity across hematologic cancers and synergy when used in combination with azacytidine.

Seclidemstat is a differentiated, oral, reversible inhibitor of LSD1, a key enzyme implicated in several cancer types. Seclidemstat is being studied in various solid tumor trials that have indicated seclidemstat has a manageable safety profile with preliminary evidence of anti-tumor activity.

“We look forward to exploring the potential of seclidemstat in Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia,” said Nadeem Mirza, M.D., M.P.H., Senior Vice President Clinical Development at Salarius Pharmaceuticals. “These are hard to treat blood cancers, and if patients progress to Acute Myeloid Leukemia, they face a bleak prognosis. New treatment options are desperately needed, and this study provides hope to patients battling these devastating cancers.”

The dose-escalation stage of the Phase 1/2 trial will enroll patients aged 18 and older with MDS or CMML. Patients will receive 75 mg/m² of azacytidine, administered intravenously (IV) or subcutaneously (SC), on days one through seven of each 28-day cycle in combination with an escalating, twice-daily dose of seclidemstat administered as an oral tablet. Once MTD of the combination is determined by the Safety Review Committee, the study enters a dose-expansion stage that will enroll additional patients to confirm the safety and tolerability profile for seclidemstat in combination with azacytidine and capture efficacy data regarding overall response rate, duration of response, leukemia-free survival, relapse-free survival, and overall survival.

“We are very excited about this collaboration to research seclidemstat as a potential new treatment for Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia, two aggressive and potentially deadly blood cancers,” stated David Arthur, CEO of Salarius Pharmaceuticals. “This clinical trial represents an additional step in developing seclidemstat for use in hematologic and other cancers and is based on preclinical and clinical research suggesting that LSD1 inhibition has an effect on hematologic cancers. We are optimistic that seclidemstat could hold a key to treating these and other devastating cancers where LSD1 inhibition plays a role in the development and progression of cancer.”

Funding for the trial will be provided by MD Anderson and Salarius, with Salarius also providing seclidemstat to investigators for the clinical trial. More information on the clinical trial is available at www.clinicaltrials.gov.

About Salarius Pharmaceuticals

Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options. Salarius’ lead candidate, seclidemstat, is being studied as a potential treatment for pediatric cancers, solid tumors and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma and FET-translocated sarcomas. Seclidemstat has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation in Ewing sarcoma from the U.S. Food and Drug Administration. Salarius is also developing seclidemstat for several cancers with high unmet medical need, with a second Phase 1/2 clinical study in advanced solid tumors, including prostate, breast, and ovarian cancers. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and was also a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn.

Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties and include statements: about the scope of the expected collaboration; about the findings of any study conducted through the collaboration including any findings regarding the safety and tolerability of seclidemstat in combination with azacytidine in the treatment of Myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML); that discuss the role of seclidemstat in any studies conducted through the collaboration; related to how findings in any study involving seclidemstat may conform to any findings from previous preclinical and clinical trials; preclinical and clinical research results and the ability and potential for LSD1 inhibition to address hematological cancers; and related to the ability to determine the MTD of the combination or entering a dose-expansion stage. All statements, other than statements of historical facts, included in this press release regarding the Company’s plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words “estimate,” “project,” “intend,” “expect,” “believe,” “anticipate,” “will,” “plan,” “could,” “may” and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements including receipt of regulatory approvals and market conditions. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact

Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA)
(212) 375-2664 
[email protected]

Johanna Bennett (media)
(212) 375-2686 
[email protected]